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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K260527

510(k) cleared

FACE4D Aligner

Avinent Implant System S.L.U. · Jul 2, 2026 · K260527

FDA cleared the FACE4D Aligner from Avinent Implant System S.L.U. on Jul 2, 2026 under K260527, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 17, 2026. The decision came 135 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Avinent Implant System S.L.U. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260527?

K260527 is the FDA 510(k) for FACE4D Aligner, submitted by Avinent Implant System S.L.U.. FDA's decision date was Jul 2, 2026, under product code NXC (Aligner, Sequential).

Who makes the FACE4D Aligner?

Avinent Implant System S.L.U., based in Barcelona, is the applicant of record for K260527.

How long did the K260527 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jul 2, 2026, 135 days later.

← All decisions in July 2026